Senior Consultant

I am a results-driven, hands-on QA and QMS expert with extensive experience in the pharma industry. My expertise includes GxP and Data Integrity requirements, Business Analysis, Project Management, Product Owner, Computer System Validation CSV & CSA

• 21 CFR Part 11
• Business Analysis
• Computer system validation (CSV)
• Data integrity
• GXP
• Projektmanagement (IT)
• QMS
• Qualitätsmanagement / QS / QA (IT)
• Requirement Analyse
• Teamleiter

Expert Knowledge on Eu GxP requirements, FDA 21 CFR Part 11, ISPE GAMP 5, MHRA, PDA TR84, PIC/S guidline, WHO guidlines for Computer Systems Validation, Computer Software Assurance and Data Integrity.
I have worked as a business analyst, gathering requirements and mapping the processes, performing risk analysis (FMEA) and gap analysis using critical thinking, writing functional specifications, user stories, acceptance criteria, test scripts, validation deliverable documents, defect/deviation reports. I worked with Adonis as a BMPN tool for depicting business processes, and I have experience in working in an agile framework using Jira and Confluence.
I have extensive knowledge in systems used in the pharmaceutical industry such as SAP S/4 Hana QM, PM, MM and EWM, Veeva Vault eQMS, RIM & Submissions DMS and clinical Vault eTMF, Trackwise, LIMS, MES, chromatography software, as well as the SDLC documentation (Solution Manager 7.2) and testing tools such as HP ALM.
I worked also in roles in Hypercare phase, using Service Now for incident management and change management, I was involved in Change Management tasks and Training roll-out